What is a Qualified Person?

A Qualified Person (QP) is a legal term described in both European and UK medicines legislation as far back as 1974.  QPs are legally responsible for certifying batches of medicines for sale or supply within the EU.  The QP therefore has tremendous responsibilities for public safety.  QPs typically work within the pharmaceutical industry mainly within quality departments.  Movement into regulatory affairs is a common avenue for QPs wishing for a change.  Other avenues include training, consultancy/contracting or turning to the darkside and joining the ranks of the medicines inspectorate!

Can anyone become a QP?

No, EU legislation has defined the requirements for eligibility for becoming a QP.  EU directive 2001/83/EC, as amended, states within Article 49 that candidates must have a university diploma/degree in one of the following disciplines; pharmacy, medicine, veterinary medicine, chemistry, pharmaceutical chemistry & technology and biology. 

Ok, I have one of those degrees - sign me up!

Not so fast, within the UK QPs must be a member of either the Royal Pharmaceutical Society, Royal Society of Chemistry or Society of Biology.  Membership of one of these bodies ensures that QPs are subject to a professional code of conduct. 

Ok, Ok, I've just graduated and joined one of the relevant professional bodies - now can I join the club?

Hold your horses, there is yet more requirements before you can be named as a QP.   The EU directive states a minimum requirement of at least 2 years practical experience within an organisation authorised to manufacture medicinal products.  This is 2 years full time experience, part time will only be counted pro-rata towards to minimum period.

The nature of EU directives allows some interpretation when transposed into UK Law.  As a result the UK legislation covering medicines (Human Medicines Regulations 2012) provides an exception to the 2 year rule.  Pharmacists are required to have a minimum of 1 year practical experience (biologists and chemists still require 2 years). 

Before you biologists & chemists start moaning, consider yourself lucky you are not German.  In Germany only pharmacists are allowed to be eligible for QP status.

finally, I'm in.....

err, not quite but the end is in sight.  Once you have your relevant degree, practical experience and joined one of the 3 bodies you can submit an application form (assuming your sponsor agrees - I'll write a separate post on this at a later date).  If your application is deemed satisfactory by panel of QP assessors then you will be called to an oral examination or viva.  The viva is your opportunity to show you are worthy of the QP title and involves usually 3 person panel firing questions and scenarios at you for approximately 1 hour.  They assess your answers and either give you a thumbs up or thumbs down. 

The QP assessors are not the final adjudicators in the process.  The final decision of whether you are truly worthy of being assigned QP status lies with the MHRA.  The MHRA will assess your CV and eligibility before naming you on a relevant license.

For those old enough and lucky enough, there was another route to the top.  When the legal basis for a QP came into force around 1975 there was a 'Grandfather clause' to enable those persons already performing the duties of a QP to become officially recognised as such.  They had it tough back then.....

Summary:

QPs certify batches of medicinal products for sale or supply within the EU and their responsibility is reflected by the extensive training requirements of these esteemed positions.